Pew Among 10 Groups Urging Senate to Pass OTC Drug Oversight Bill

Pew Among 10 Groups Urging Senate to Pass OTC Drug Oversight Bill

The Pew Charitable Trusts and nine organizations representing public health advocates, health care providers, and makers of nonprescription drugs and sunscreens urged the U.S. Senate’s Health, Education, Labor, and Pensions Committee to approve a bill to streamline the Food and Drug Administration’s regulatory system for over-the-counter (OTC) medications.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (S. 2740) would enable FDA to respond rapidly to safety concerns and evidence that a product needs dosage or labeling updates, the groups noted in an Oct. 30 letter to the committee’s leaders. The legislation incorporates Pew’s principles for reforming OTC oversight and would require that product manufacturers pay fees to FDA to help fund agency oversight.

The letter is signed by the American Academy of Allergy, Asthma & Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products Association; March of Dimes; National Association of County and City Health Officials; Pew; Protecting Access to Pain Relief Coalition; Public Access to SunScreens Coalition; and Society for Maternal-Fetal Medicine.

Antiseptic hand wash
Article

FDA Update on Permitted Antiseptic Hand Wash Ingredients Took 45 Years

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Article

Forty-five years after the Food and Drug Administration (FDA) started to update the agency-approved recipe—called a monograph—for over-the-counter hand sanitizers, it announced in April that it had finished the task. The fact that it took more than four decades illustrates why FDA, along with medical, public health, industry, and consumer interest groups, are calling for legislative reform of the monograph system.

Fact Sheet

Regulation of Over-the-Counter Drug Products Should Be Streamlined

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Fact Sheet

Americans routinely reach for over-the-counter (OTC) drugs to treat a wide variety of ailments. And they have a growing number of choices at their local drugstore: The OTC market now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers.